END-to-END COMPREHENSIVE ONE-STOP SERVICE

MabPlex provides the one stop solution for antibody drug development, helping our partners develop high quality antibody drug products for IND filing.

CRO Services

MabPlex’s CRO offers custom services for research, optimization, and development phases of your project.

CDO Services

MabPlex offers a series of integrated CMO for mAb products from antibody humanization, cell line development, to analytic development, quality standard establishment, and stability studies.

CMO Services

We provide our clients comprehensive and flexible development and manufacturing packages from early CRO to final CMO, ranging from lead optimization and cell line development to full-scale manufacturing.

FACILITY

An advanced facility with state of the art instrumentation

QMS

  • Conformance to Regulations, Client requirements and established SOPs
  • Timely release (products, materials, project reports, investigations) through First time right and Continuous Improvement

Regulatory Affair

  • Comparability assessment
  • Amendments
  • Supplements
  • CMC gap analysis
  • IND/BLA/IMPD Submissions
  • Assistance with response to FDA questions

Project Management

  • Execute each project with the highest quality and integrity standards
  • Provide exceptional customer service
  • Maintain open, honest communications that facilitates a partnership lasting well beyond the project timeline
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